Identity
- Trade Name
- OnGuard2 Bag Adaptor SP II FDA UDI
- Generic Name
- Medication transfer set FDA UDI
- Device Name
- OnGuard2 CSTD Bag Adaptor SP II a Chemfort Product FDA UDI
- Model / Reference
- 412186 FDA UDI
- Description
- OnGuard2 CSTD Bag Adaptor SP II a Chemfort Product FDA UDI
Identifiers
- Primary DI / UDI-DI
- 27290115921865 FDA UDI
- 510(k) Number
- K192866 FDA UDI
- FDA Product Code
- ONB FDA UDI
- GMDN Term
- Medication transfer set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medication transfer set
OnGuard2 Bag Adaptor SP II by Simplivia Healthcare Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medication transfer set.
- Equashield — Equashield Medical Ltd. · Class II
- Set, Administration, Intravascular — MPS MEDICAL, INC · Class II
- Set, Administration, Intravascular — MPS MEDICAL, INC · Class II
- Set, Administration, Intravascular — MPS MEDICAL, INC · Class II
- Set, Administration, Intravascular — MPS MEDICAL, INC · Class II
- Set, Administration, Intravascular — MPS MEDICAL, INC · Class II
- Set, Administration, Intravascular — MPS MEDICAL, INC · Class II
- Set, Administration, Intravascular — MPS MEDICAL, INC · Class II
Cleared under the same submission
K192866 also covers:
- ONGUARD2 20mm VIAL ADAPTOR SL with 13 mm convertor — SIMPLIVIA HEALTHCARE LTD
- OnGuard2 20mm Vial Adaptor, 10 Units — SIMPLIVIA HEALTHCARE LTD
- OnGuard2 20mm Vial Adaptor, 5 Units — SIMPLIVIA HEALTHCARE LTD
- OnGuard2 Syringe Adaptor Lock II — SIMPLIVIA HEALTHCARE LTD
- OnGuard2 Syringe Adaptor Lock II, 5 Units — SIMPLIVIA HEALTHCARE LTD
- OnGuard2 Syringe Adaptor Sterile Replacement Cap — SIMPLIVIA HEALTHCARE LTD
- OnGuard2 Syringe Adaptor, 5 Units — SIMPLIVIA HEALTHCARE LTD
- OnGuard®2 20mm Vial Adaptor II and 13mm convertor — SIMPLIVIA HEALTHCARE LTD
- OnGuard®2 CSTD 20mm Vial Adaptor and 13mm Convertor — SIMPLIVIA HEALTHCARE LTD
- OnGuard®2 CSTD 28mm Vial Adaptor — SIMPLIVIA HEALTHCARE LTD
- OnGuard®2 CSTD Bag Adaptor SP — SIMPLIVIA HEALTHCARE LTD
- OnGuard®2 CSTD Luer Lock Adaptor — SIMPLIVIA HEALTHCARE LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Simplivia Healthcare Ltd
Sources (1)
- FDA UDI 1e21001d-5338-4a93-8306-7f345cc312ec 35 fields · synced Jun 8, 2026